Recruiting
Phase 1

AWT020

Sponsor:

Anwita Biosciences

Code:

NCT07822919

Conditions

Advanced Cancers (Solid Tumors)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AWT020

Study Details

Brief summary:

This study is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020.

Conditions

Advanced Cancers (Solid Tumors)

Study ID

NCT07822919

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older; able to provide written informed consent and comply with study visits and procedures.
  • Pathologically confirmed, unresectable advanced solid tumor.
  • Disease progression after at least one systemic therapy, with no beneficial standard option available or tolerated. Disease-specific prior therapy requirements apply to urothelial and renal cell carcinoma cohorts.
  • At least one measurable lesion by RECIST version 1.1, ECOG performance status of 0 or 1, and life expectancy of at least 3 months.
  • Adequate bone marrow, renal, hepatic, coagulation, and cardiac function as defined in the protocol.
  • Meets protocol requirements for reproductive safety and tumor tissue availability.

Exclusion Criteria:

  • Relevant hypersensitivity or intolerance to prior immunotherapy, interleukin-2 based therapy, monoclonal antibodies, or the study treatment; or prior immunotherapy discontinued because of an immune-related adverse event.
  • Untreated or unstable central nervous system metastases, leptomeningeal disease, or brainstem metastases.
  • Clinically significant autoimmune or skin disease requiring systemic treatment; Stevens-Johnson syndrome or toxic epidermal necrolysis; or current, suspected, or steroid-treated interstitial lung disease/pneumonitis.
  • Unresolved toxicity from prior therapy, or recent anticancer treatment, major surgery, live vaccine, or other restricted therapy within protocol-defined washout periods.
  • Clinically significant cardiac, thromboembolic, cerebrovascular, gastrointestinal, bleeding, or other uncontrolled medical condition.
  • Active or recent severe infection.
  • Prior allogeneic transplantation or adoptive cellular immunotherapy; concurrent investigational therapeutic trial; or pregnancy or breastfeeding.
  • Another malignancy within 5 years, except permitted low-risk or in situ cancers; or any condition that increases risk, prevents consent or compliance, or could interfere with study interpretation.

Study Design

Enrollment

96 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AWT020

Participants receiving intravenous infusion of AWT020

Interventions

AWT020

Participants receiving AWT020 once every three weeks at designated dose levels

Primary outcome measure

  • Adverse Events (AEs) [Safety] [ Time Frame: Throughout the study up to 30 months ]
  • Serious Adverse Events (SAEs) [Safety] [ Time Frame: Throughout the study up to 30 months ]
  • Treatment-emergent Adverse Events (TEAEs) [Safety] [ Time Frame: Throughout the study up to 30 months ]
  • Adverse Events of Special Interest (AESIs) [Safety] [ Time Frame: Throughout the study up to 30 months ]
  • Dose-limiting Toxicities (DLTs) [Tolerability] [ Time Frame: Throughout the study up to 30 months ]

Central Contacts and Locations

Central contacts

Laksmi Wilson

650-600-9828lwilson@anwitabio.com

Locations

Florida Clinical Trials Group

Recruiting

Plantation, Florida, United States, 33322

Contacts

Spencer Herard

772-297-3057herards@floridactg.com

Principal Investigator:

Harshad Amin, MD

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Maybelle De La Rosa

703-783-4518mdelarosa@nextoncology.com

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

Anwita Biosciences

Last update posted

Sep 23, 2026

Last verified

Sep, 2026

Keywords

  • AWT020
  • anti-PD1
  • Interleukine-2
  • Phase 1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Anwita Biosciences on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.